Responsible for planning, developing and buying materials, parts, supplies and equipment in a timely and cost-effective way; timely manner while maintaining appropriate quality standards and specifications. Lead the procurement group in all phases. Implement procurement strategy and policies. Forecast procurement needs. Create and implement Key Performance Indicators of procurement process. Preparation of weekly & monthly management reports Vendor Management - Manage vendor relationships and assist in building effective partnerships. Responsible for preparing, revising, and implementing Standard Operating Procedures (SOPs). Identify and develop training opportunities for purchase personnel. Review quotations & order materials and equipments as per negotiated and appropriately approved by the management. Price negotiation of the products & equipments and preparation of Service Level Agreements (SLA), if any, with the vendor, after discussion with the management & finance department. Preparation of PO/WO - Prepare purchase requisitions, approve and issues purchase orders in accordance with company policy and negotiated terms and conditions. Maintaining & updating procurement, indent files, purchase order files and work order files, as they will be audited. Discuss defective or unacceptable material / new goods / equipment's / services with users, vendors and others to determine cause of problem and take corrective and preventative action. Ensure supplier compliance with site and company requirements for safety. Develop and review purchase requests and ensure authorization as necessary to facilitate the timely purchase of materials & equipment. Maintains & updation of Material Safety Data Sheets (MSDS) for all chemicals ordered, from the respective suppliers. Maintain and update a master list of Purchase orders and Work orders with appropriate controls and traceability to the soft copies of the purchase orders and work orders with the final quotations. Liaise with Accounts Payable Department to ensure accurate and timely payment of invoices, as necessary for the business with the supplier. Liaising with Banks / other Government offices / accounts department if importing equipment's. Stock verification. Preparation of documentation pertaining to shipments. Follow-up & co-ordination with clearing agent for import shipments and any other clearance. Co-ordination with the vendors and suppliers for obtaining quotations, on time supply of ordered items and follow-up for delayed supplies. Updating list of approved suppliers and vendors, as per SOP. Ensure proper recording of goods receipts and dispatch. Participates in the financial activities, budgeting processes and business reviews of the Purchasing Department. Preparation of Monthly & Yearly closing stock report with physical verification Verification of Monthly & Yearly material consumption report Ensuring inward & outward of goods & services in place.
Role & responsibilities Activities to be performed with the compliance of ISMS requirements by means of confidentiality, integrity, and availability. Data integrity must be followed and ensured in all the respective responsibilities. Audits: Sponsor Audits: Managing the sponsor audits as a whole, from pre requestees to close out meeting. Addressing audit observations within timeline. Follow up sponsors for certificates/clearance. Standard Audits: Ensuring the readiness for Audit. Supporting the cross functions for readiness requirements. Managing the audit from open meeting to close out meeting. Addressing the observations. Vendor Audits: Initiating the vendor qualification process based on requirements. Conducting onsite vendor audits with respect to ISO 9001:2015, ISO27001:2022 or other applicable ISO standards. Assessing the potency of vendors for iVRS service. Issuing audit observations, verification of CAPA and issuance of certificates. Verifying the surveillance audit due dates and initiating the surveillance audits within timeline. Score card updates for vendors. Internal Audit: Conducting Internal audit as per iVRS internal audit SOP, Ensuring the compliance with respect to internal SOPs, regulatory guidelines, etc Issuing the audit reports, verification of CAPA, closing the Audits. MRM: Facilitating the MRM upon completion of Internal audit under MR supervision Requesting cross functional inputs Making the MRM presentation Analytical Development: Develop documentation and system as per Quality Management System and ensure its implementation in the laboratory. Preparation of manuals and policies. To review the Manuals, Standard Operating Procedures, and other quality documents and approval of the same. Review and Approval of study protocols, Validation protocols, Qualification protocols and CSV protocols Review and approval of Validation reports, Qualification reports and CSV execution and reports. Develop, implement, and manage processes to ensure that studies / project activities meet required specifications for quality, function, and reliability prior to submission of data to the sponsor/customer. Review and approve of project / study documents related to analytical department to ensure its compliance with inhouse SOPs, study specific protocols, and applicable regulatory requirements & guidelines. Monitoring and ensure that the lab is following practices/ procedures laid down by way of regular planned and unplanned audits. Customer query- to register the query received from customer and handling the investigations Review, monitoring and data compilation of customer queries. Implementing, maintaining and improving the established analytical lab and in-process processes and methods. Verifying and approving the Laboratory incidents and investigations To oversee the activities with respect to Quality Management Systems and Learning and Development. Verification and approval of calibration documents. Verification of Audit trials in various instruments for validation, study and calibrations. Verification of biannual audit trails Attending all mandatory trainings (as applicable) without fail. Clinical Development: Conduct inspections or test checks to determine if all studies are conducted in accordance with the Principles of Good Clinical Practice Review of protocol and other study related documents Site visits whenever required. QMS: Verification of Procedures for its adequacy, To review and approve master list of SOPs. (as a backup to the designated employee) Preparation of new procedures and revision of existing procedures. Preparation, review, approval of Quality assurance procedures. Review and approval of cross function procedures. Verification, authorization/approval/Closure of Change controls, LIR and other QMS forms. Verification and approval of QMS trending. Review IQ, OQ, PQ records, Calibration certificates and Computer System Validation for Automated Software, as per 21 CFR Part 11 compliance. Ensure to follow and accomplish the Quality Objectives and ISMS objectives. Preparation / Verification of QA and ISMS objectives and actuals, Actuals, Risk assessments, Asset lists, etc Training: Ensuring the annual training schedule. Ensuring the mandatory trainings are conducted as per schedule. Ensuring the identified trainings are conducted for team members. Planning regulatory and QA trainings. Conducting BCP-DRT meetings. Ensuring the surveillance audits and ensuring the internal feedbacks.